Full Text View
Tabular View
No Study Results Posted
Related Studies
Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2009
First Received: April 14, 2009   Last Updated: April 20, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00881647
  Purpose

This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.


Condition Intervention
Post-Traumatic Stress Disorder
Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Sleep latency (SL), minutes of wake after sleep onset (WASO), and sleep efficiency [ Time Frame: Measured after 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: November 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive an 8-week course of cognitive behavioral therapy for insomnia.
Other: Cognitive Behavioral Treatment for Insomnia (CBT-I)
CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
2: No Intervention
Participants will be placed on a waitlist for 8 weeks.

Detailed Description:

Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary insomnia but has been successfully used to treat insomnia in people with other disorders. Insomnia is the most commonly reported complaint of patients receiving treatment for post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in people with PTSD.

Participation in this study will last 10 months. At study entry, participants will complete a series of eligibility assessments, including a clinical interview, a medical screening, a urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week, participants will complete baseline assessments of sleep behaviors. The assessments will include the following: filling out a set of questionnaires about health, mood, sleeping patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like device, called an Actigraph, that records activity level during wakefulness and sleep; completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter, 1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep recorder connected to one's head to measure different stages of sleep.

After the week of sleep assessments, participants will be randomly assigned to one of two groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete eight weekly therapy sessions targeted at improving quality of sleep and resolving problems with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a questionnaire booklet with similar questions to those completed in the eligibility screening. After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep problems. After the second set of sleep assessments, the waitlist group will be offered CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These follow-up assessments will involve repeating both the sleep assessments and the clinical interview performed after the 8-week intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic PTSD for at least 3 months
  • Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months
  • Persistent residual insomnia

Exclusion Criteria:

  • Conditions or substances that may be associated with comorbid insomnia independent of PTSD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881647

Contacts
Contact: Carrie Bair 888-567-6337 ptsd.research@ncire.org
Contact: Maryann Lenoci 415-750-6624

Locations
United States, California
VA Medical Center, San Francisco Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Thomas C. Neylan, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas C. Neylan, MD University of California, San Francisco/VA Medical Center, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco/VA Medical Center, San Francisco ( Thomas C. Neylan, MD, Principal Investigator )
Study ID Numbers: R34 MH077667, DATR AD-TS
Study First Received: April 14, 2009
Last Updated: April 20, 2009
ClinicalTrials.gov Identifier: NCT00881647     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
PTSD
Insomnia Disorder
Insomnia
CBT

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on September 04, 2009